Electro-mechanical surgical device

ABSTRACT

A flexible shaft includes a flexible, elongated outer sheath, at least one drive shaft disposed within the outer sheath and a moisture sensor disposed within the outer sheath configured to detect moisture within the outer sheath. Another flexible shaft includes a flexible, elongated outer sheath, at least one flexible drive shaft disposed within the outer sheath and a coupling connected to a distal end of the outer sheath configured to couple to a surgical attachment. 
     A sleeve includes an elongated shaft configured to receive a flexible shaft therein and a securing arrangement configured to selectively and variably retain the elongated shaft in any one of a number of longitudinal positions along the flexible shaft. 
     A surgical system includes an electro-mechanical driver, an elongated, flexible sheath, at least one drive shaft disposed within the flexible sheath, a surgical attachment coupled to the at least one drive shaft, the electro-mechanical driver configured to drive the surgical attachment, a shape-retaining sleeve, at least a portion of the flexible sleeve being disposed in the shape-retaining sleeve, the shape-retaining sleeve configured to maintain the at least portion of the flexible sheath in a predetermined shape, and an arrangement variably securing the shape-retaining member to the flexible sheath in any one of a number of longitudinal positions along the flexible sheath.

CROSS-REFERENCE TO RELATED APPLICATIONS

This is a continuation-in-part of U.S. patent application Ser. No.09/887,789, filed on Jun. 22, 2001, which is a continuation-in-part ofU.S. patent application Ser. No. 09/836,781, filed on Apr. 17, 2001,which is a continuation-in-part of U.S. patent application Ser. No.09/723,715, filed on Nov. 28, 2000, which is a continuation-in-part ofU.S. patent application Ser. No. 09/324,451, filed on Jun. 2, 1999, acontinuation-in-part of U.S. patent application Ser. No. 09/324,452,filed on Jun. 2, 1999, a continuation-in-part of U.S. patent applicationSer. No. 09/351,534, filed on Jul. 12, 1999, a continuation-in-part ofU.S. patent application Ser. No. 09/510,923, filed on Feb. 22, 2000,which is a continuation-in-part of U.S. patent application Ser. No.09/324,452, a continuation-in-part of U.S. patent application Ser. No.09/510,927, filed on Feb. 22, 2000, which is a continuation-in-part ofU.S. patent application Ser. No. 09/324,452, and a continuation-in-partof U.S. patent application Ser. No. 09/510,932, filed on Feb. 22, 2000,each of which is expressly incorporated herein by reference in itsentirety.

FIELD OF THE INVENTION

The present invention relates to an electro-mechanical surgical device.

BACKGROUND INFORMATION

The literature is replete with descriptions of surgical devices. Forexample, U.S. Pat. No. 4,705,038 to Sjostrom et al. describes a surgicalsystem for powered instruments. The system includes a handpiececontaining a motor and including a recess adapted to receive one of aplurality of surgical devices. A pair of reed switches is disposedwithin the recess, and each of the surgical devices includes one or twomagnets adapted to actuate the reed switches in a particular combinationwhen the device is assembled with the handpiece. The combination of reedswitches activated by the magnets of the assembled handpiece andsurgical device identifies to the system the surgical device soassembled with the handpiece. The number of possible surgical devicesidentifiable by this system is limited to the four possible combinationof up to two magnets.

U.S. Pat. No. 4,995,877 to Ams et al. describes a device with arotationally-driven surgical instrument. The device includes a hand-heldelement containing a driving motor for driving a tool insert. The devicefurther includes a control unit having a storage unit for storingoperational data manually set by the user of the device. Such data maybe transferred to a code carrier, which is insertable into a plug-infacility.

U.S. Pat. No. 5,249,583 to Mallaby describes an electronic biopsyinstrument with wiperless position sensors. A slotted disc and a cam areaffixed to a drive shaft, which is driven by a motor. A pair of sensorsis arranged so that each sensor is activated when the slot of theslotted disc is positioned over the sensor to thereby determine theposition of a cannula and a stylet of the instrument. The sensors,slotted disc, cam, motor and rechargeable batteries for powering theinstrument are contained within a housing of the instrument.

U.S. Pat. No. 5,383,880 to Hooven describes an endoscopic surgicalsystem with sensing means. The instrument includes a motor disposedwithin a hand-held housing. A sensor is provided in the head of aninstrument of the system for sensing the blood oxygen content ofadjacent tissue.

Similarly, U.S. Pat. No. 5,395,033 to Byrne et al. describes anendoscopic surgical instrument having a pair of jaws. A permanent magnetis disposed in a distal end of one of the jaws, and a magneto-resistivesensor is disposed in a distal end of the other one of the jaws. Themagnet produces a magnetic field between the jaws, and the sensormeasures the variations in the magnetic field so that the distancebetween the jaws may be determined.

U.S. Pat. No. 5,467,911 to Tsuruta et al. describes a surgical devicefor stapling and fastening body tissues. The device includes anoperation section and an insertion section, which is detachablyattachable to the operation section.

U.S. Pat. Nos. 5,518,163, 5,518,164 and 5,667,517, all to Hooven,describe an endoscopic surgical system, which includes a motor disposedin a handle portion. A sensing member, which is used to sense the bloodoxygen content of adjacent tissue, is disposed in a head of theinstrument. A contact is also provided in the head of the instrument.When a firing nut of the system has moved forward in the head to driveand form surgical staples disposed therein, the firing nut engages thecontact, thereby reversing the motor to retract the firing nut.

U.S. Pat. No. 5,653,374 to Young et al., U.S. Pat. No. 5,779,130 toAlesi et al. and U.S. Pat. No. 5,954,259 to Viola et al. describe aself-contained powered surgical apparatus, which includes a motorassembly and power source disposed within a hand-held instrument body.

These instruments and systems described above suffer numerousdisadvantages. For example, in several of the above-describedinstruments and systems, a motor is disposed within a handle of theinstrument. Due to size considerations, these motors generally providelimited torque. In certain of the instruments and systems describedabove, a battery is provided within the handle for powering the motor.Such battery systems, however, provide limited electrical power to themotors, further limiting the torque output by the motors.

In addition, it is generally not possible to accurately ascertain thepositions of the operative elements of the aforementioned instrumentsand systems.

A further disadvantage of the above-described instruments and systems isthat such instruments and systems typically require manual manipulationand operation. When a motor is provided in the handle of suchinstruments, manual manipulation and operation is awkward and cumbersometo the operator.

SUMMARY

In one example embodiment of the present invention, a flexible shaft isprovided that includes an flexible, elongated outer sheath, the sheathbeing formed from an autoclavable material, and at least one drive shaftdisposed in the outer sheath.

In another example embodiment of the present invention, a flexible shaftis provided, including: a flexible, elongated outer sheath; at least onedrive shaft disposed within the outer sheath; and a moisture sensordisposed within the outer sheath configured to detect moisture withinthe flexible outer sheath.

In still another example embodiment a flexible shaft is provided,including: a flexible, elongated outer sheath; at least one drive shaftdisposed within the outer sheath; and a coupling connected to a distalend of the outer sheath.

In yet another example embodiment a shaft for a surgical system isprovided, including: a flexible, elongated outer sheath; at least onedrive shaft disposed within the outer sheath; and an outer sleeveconfigured to retain the outer sheath in a predetermined shape.

In still another example embodiment a surgical device is provided,including an electro-mechanical driver device; a flexible, elongatedouter sheath connected to the electro-mechanical driver device; and atleast one drive shaft disposed within the outer sheath.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of an electro-mechanical surgical deviceaccording to the present invention.

FIG. 2 is a side elevational view, partially in section, of a flexibleshaft of the electro-mechanical surgical device illustrated in FIG. 1.

FIG. 3 is a cross-sectional view of the flexible shaft taken along theline 3-3 shown in FIG. 2.

FIG. 4 is a rear end view of a first coupling of the flexible shaftillustrated in FIG. 2.

FIG. 5 is a front end view of a second coupling of the flexible shaftillustrated in FIG. 2.

FIG. 6 is a schematic view illustrating a motor arrangement of theelectro-mechanical surgical device illustrated in FIG. 1.

FIG. 7 is a schematic view of the electro-mechanical surgical deviceillustrated in FIG. 1.

FIG. 8 is a schematic view of an encoder of the flexible shaftillustrated in FIGS. 2 and 3.

FIG. 9 a is a schematic cross-sectional side view of a first exampleembodiment of a circular surgical stapler attachment used in connectionwith the electro-mechanical surgical device illustrated in FIG. 1.

FIG. 9 a is a schematic cross-sectional side view of a second exampleembodiment of a circular surgical stapler attachment used in connectionwith the electro-mechanical surgical device illustrated in FIG. 1.

FIG. 9 c is an exploded view of an example embodiment of a geararrangement of the second example embodiment of the circular surgicalstapler attachment illustrated in FIG. 9 b.

FIG. 10 is a schematic view of a memory device of the first exampleembodiment of a circular surgical stapler attachment illustrated in FIG.9 b.

FIG. 11 is a schematic view of a wireless remote control unit of theelectro-mechanical surgical device illustrated in FIG. 1.

FIG. 12 is a schematic view of a wired remote control unit of theelectro-mechanical surgical device illustrated in FIG. 1.

FIG. 13 illustrates a flowchart of a first example embodiment of a mainoperating program for operating the electro-mechanical surgical deviceillustrated in FIG. 1.

FIGS. 14 a to 14 d illustrate a flowchart of a first example embodimentof a fire routine for a circular surgical stapler attachment, such asthat illustrated in FIGS. 9 a to 9 c.

FIGS. 15 a and 15 b illustrate a flowchart of a clamp routine for acircular surgical stapler attachment, such as that illustrated in FIGS.9 a to 9 c.

FIG. 16 illustrates a flowchart of an unclamp routine for a circularsurgical stapler attachment, such as that illustrated in FIGS. 9 a to 9c.

FIGS. 17 a to 17 d illustrate a flowchart of a second example embodimentof a main operating program for operating the electro-mechanicalsurgical device illustrated in FIG. 1.

FIGS. 18 a and 18 b illustrate a flowchart of a self-test operatingprogram for the electro-mechanical surgical device illustrated in FIG.1.

FIGS. 19 a to 19 e illustrate a flowchart for a field test operatingprogram for the electro-mechanical surgical device illustrated in FIG.1.

FIGS. 20 a to 20 c illustrate a flowchart for a main operating programfor operating the circular surgical stapler attachment, such as thatillustrated in FIGS. 9 a to 9 c.

FIGS. 21 a to 21 d illustrate a flowchart of a second example embodimentof a fire routine for a circular surgical stapler attachment, such asthat illustrated in FIGS. 9 a to 9 c.

FIGS. 22 a and 22 b illustrate a flowchart of a second exampleembodiment of a clamp routine for a circular surgical staplerattachment, such as that illustrated in FIGS. 9 a to 9 c.

FIGS. 23 a and 23 b illustrate a flowchart of a second exampleembodiment of an unclamp routine for a circular surgical staplerattachment, such as that illustrated in FIGS. 9 a to 9 c.

FIG. 24 a is an exploded view of an example detachable second coupling.

FIG. 24 b is an assembled view of the example detachable second couplingillustrated in FIG. 24 a.

FIG. 25 is a sectional view of a fully assembled example detachablesecond coupling including a flexible strip locking mechanism.

FIGS. 26 a to 26 d illustrates an operational sequence for locking andunlocking the fully assembled example detachable second couplingillustrated in FIG. 25.

FIG. 27 illustrates example drive shaft members of a detachable secondcoupling.

FIG. 28 a illustrates an exploded view of an example connectionmechanism for connecting a second coupling to a surgical attachment.

FIG. 28 b illustrates an assembled view of an example connectionmechanism for connecting a second coupling to a surgical attachment.

FIG. 28 c illustrates an sectional view of an example connectionmechanism for connecting a second coupling to a surgical attachment.

FIG. 29 illustrates an example PCB board for use in a flexible shaft.

FIG. 30 a illustrates an exploded view of a rigid sleeve.

FIG. 30 b illustrates an assembled view of a rigid sleeve.

FIG. 30 c illustrates a sectional view of a rigid sleeve.

FIG. 31 illustrates an example flexible shaft including a moisturesensor for detecting moisture.

FIG. 32 illustrates an example moisture sensor.

DETAILED DESCRIPTION

Those skilled in the art will gain an appreciation of the presentinvention from a reading of the following description when viewed inconjunction with the accompanying drawings of FIGS. 1 to 32, inclusive.The individual reference characters designate the same or similarelements throughout the several views.

Referring to FIG. 1, there is seen a perspective view of anelectro-mechanical surgical device 10 according to an example embodimentof the present invention. Electro-mechanical surgical device 10 mayinclude, for example, a remote power console 12, which includes ahousing 14 having a front panel 15. Mounted on front panel 15 are adisplay device 16 and indicators 18 a, 18 b, which are more fullydescribed hereinbelow. A shaft 20 may extend from housing 14 and may bedetachably secured thereto via a first coupling 22. The shaft 20 may beflexible, rigid, articulable, articulatable, etc. Although shaft 20 isreferred to below as a flexible shaft 20, it should be understood thatreference to a flexible shaft 20 is merely one example embodiment of theshaft 20 and that shaft 20 is in no way limited to a flexiblearrangement. The distal end 24 of flexible shaft 20 may include a secondcoupling 26 adapted to detachably secure a surgical instrument orattachment to the distal end 24 of flexible shaft 20. The surgicalinstrument or attachment may be, for example, a surgical stapler, asurgical cutter, a surgical stapler-cutter, a linear surgical stapler, alinear surgical stapler-cutter, a circular surgical stapler, a circularsurgical stapler-cutter, a surgical clip applier, a surgical clipligator, a surgical clamping device, a vessel expanding device, a lumenexpanding device, a scalpel, a fluid delivery device or any other typeof surgical instrument. Such surgical instruments are described, forexample, in U.S. patent application Ser. No. 09/324,451, entitled “AStapling Device for Use with an Electromechanical Driver Device for Usewith Anastomosing, Stapling, and Resecting Instruments,” U.S. patentapplication Ser. No. 09/324,452, entitled “Electromechanical DriverDevice for Use with Anastomosing, Stapling, and Resecting Instruments,”U.S. patent application Ser. No. 09/351,534, entitled “AutomatedSurgical Stapling System,” U.S. patent application Ser. No. 09/510,926,entitled “A Vessel and Lumen Expander Attachment for Use with anElectromechanical Driver Device,” U.S. patent application Ser. No.09/510,927, entitled “Electromechanical Driver and Remote SurgicalInstruments Attachment Having Computer Assisted Control Capabilities,”U.S. patent application Ser. No. 09/510,931, entitled “A Tissue StaplingAttachment for Use with an Electromechanical Driver Device,” U.S. patentapplication Ser. No. 09/510,932, entitled “A Fluid Delivery Mechanismfor Use with Anastomosing, Stapling, and Resecting Instruments,” andU.S. patent application Ser. No. 09/510,933, entitled “A Fluid DeliveryDevice for Use with Anastomosing, Stapling, and Resecting Instruments,”each of which is expressly incorporated herein in its entirety byreference thereto.

Referring to FIG. 2, there is seen a side view, partially in section, offlexible shaft 20. According to one embodiment, flexible shaft 20includes a tubular sheath 28, which may include a coating or othersealing arrangement to provide a fluid-tight seal between the interiorchannel 40 thereof and the environment. Sheath 28 may be formed of atissue-compatible, sterilizable elastomeric material. The sheath 28 mayalso be formed of a material that is autoclavable. The sheath 28 may beformed of a material having a high or relatively high lubricity. Forexample, sheath 28 may include Teflon™ (i.e., a fluoropolymer, e.g.,polytetrafluoroethylene—“PTFE”), silicone, a Teflon™/siliconecombination, such as, for example, SIL-KORE™ (made by W.L. Gore &Associates). Disposed within the interior channel 40 of flexible shaft20, and extending along the entire length thereof, may be a firstrotatable drive shaft 30, a second rotatable drive shaft 32, a firststeering cable 34, a second steering cable 35, a third steering cable36, a fourth steering cable 37 and a data transfer cable 38. FIG. 3 is across-sectional view of flexible shaft 20 taken along the line 3-3 shownin FIG. 2 and further illustrates the several cables 30, 32, 34, 35, 36,37, 38. Each distal end of the steering cables 34, 35, 36, 37 is affixedto the distal end 24 of the flexible shaft 20. Each of the severalcables 30, 32, 34, 35, 36, 37, 38 may be contained within a respectivesheath.

The first rotatable drive shaft 30 and the second rotatable drive shaft32 may be configured, for example, as highly flexible drive shafts, suchas, for example, braided or helical drive cables. It should beunderstood that such highly flexible drive cables may have limitedtorque transmission characteristics and capabilities. It should also beunderstood that surgical instruments, such as the circular surgicalstapler attachment 250 illustrated in FIG. 9 a and the circular surgicalstapler attachment 2250 illustrated in FIGS. 9 b and 9 c and describedbelow, or other attachments detachably attachable to the flexible shaft20 may require a higher torque input than the torque transmittable bythe drive shafts 30, 32. The drive shafts 30, 32 may thus be configuredto transmit low torque but high speed, the high speed/low torque beingconverted to low speed/high torque by gearing arrangements disposed, forexample, at the distal end and/or the proximal end of the drive flexibleshaft 20, in the surgical instrument or attachment and/or in the remotepower console 12. It should be appreciated that such gearingarrangement(s) may be provided at any suitable location along the powertrain between the motors disposed in the housing 14 and the attachedsurgical instrument or other attachment detachably attachable to theflexible shaft 20. Such gearing arrangement(s) may be provided in thesurgical instrument or other attachment detachably attachable to theflexible shaft 20. Such gearing arrangement(s) may include, for example,a spur gear arrangement, a planetary gear arrangement, a harmonic geararrangement, cycloidal drive arrangement, an epicyclic gear arrangement,etc. An example embodiment of a circular surgical stapler attachment2250 having a gearing arrangement for converting high speed/low torqueto low speed/high torque is illustrated in FIGS. 9 b and 9 c anddescribed hereinbelow.

Referring now to FIG. 4, there is seen a rear end view of first coupling22. First coupling 22 includes a first connector 44, a second connector48, a third connector 52 and a fourth connector 56, each rotatablysecured to first coupling 22. Each of the connectors 44, 48, 52, 56includes a respective recess 46, 50, 54, 58. As shown in FIG. 4, eachrecess 46, 50, 54, 58 may be hexagonally shaped. It should beappreciated, however, that the recesses 46, 50, 54, 58 may have anyshape and configuration to non-rotatably couple and rigidly attach theconnectors 44, 48, 52, 56 to respective drive shafts of the motorarrangement contained within the housing 12, as more fully describedbelow. It should be appreciated that complementary projections may beprovided on respective drive shafts of the motor arrangement to therebydrive the drive elements of the flexible shaft 20 as described below. Itshould also be appreciated that the recesses may be provided on thedrive shafts and complementary projections may be provided on theconnectors 44, 48, 52, 56. Any other coupling arrangement configured tonon-rotatably and releasably couple the connectors 44, 48, 52, 56 andthe drive shafts of the motor arrangement may be provided.

One of the connectors 44, 48, 52, 56 is non-rotatably secured to thefirst drive shaft 30, and another one of the connectors 44, 48, 52, 56is non-rotatably secured to the second drive shaft 32. The remaining twoof the connectors 44, 48, 52, 56 engage with transmission elementsconfigured to apply tensile forces on the steering cables 34, 35, 36, 37to thereby steer the distal end 24 of the flexible shaft 20. The datatransfer cable 38 is electrically and logically connected with dataconnector 60. Data connector 60 includes, for example, electricalcontacts 62, corresponding to and equal in number to the number ofindividual wires contained in the data cable 38. First coupling 22includes a key structure 42 to properly orient the first coupling 22 toa mating and complementary coupling arrangement disposed on the housing12. Such key structure 42 may be provided on either one, or both, of thefirst coupling 22 and the mating and complementary coupling arrangementdisposed on the housing 12. First coupling 22 may include aquick-connect type connector, which may use, for example, a simplepushing motion to engage the first coupling 22 to the housing 12. Sealsmay be provided in conjunction with any of the several connectors 44,48, 52, 56, 60 to provide a fluid-tight seal between the interior offirst coupling 22 and the environment.

Referring now to FIG. 5, there is seen a front end view of the secondcoupling 26 of flexible shaft 20. Second coupling 26 includes a firstconnector 66 and a second connector 68, each being rotatably secured tothe second coupling 26 and each being non-rotatably secured to a distalend of a respective one of the first and second drive shafts 30, 32. Aquick-connect type fitting 64 is provided on the second coupling 26 fordetachably securing the surgical instrument or attachment thereto. Thequick-connect type fitting 64 may be, for example, a rotaryquick-connect type fitting, a bayonet type fitting, etc. A key structure74 is provided on the second coupling 26 for properly aligning thesurgical instrument or attachment to the second coupling 26. The keystructure or other arrangement for properly aligning the surgicalinstrument or attachment to the flexible shaft 20 may be provided oneither one, or both, of the second coupling 26 and the surgicalinstrument or attachment. In addition, the quick-connect type fittingmay be provided on the surgical instrument or attachment. A dataconnector 70, having electrical contacts 72, is also provided in thesecond coupling 26. Like the data connector 60 of first coupling 22, thedata connector 70 of second coupling 26 includes contacts 72electrically and logically connected to the respective wires of datatransfer cable 38 and contacts 62 of data connector 60. Seals may beprovided in conjunction with the connectors 66, 68, 70 to provide afluid-tight seal between the interior of second coupling 26 and theenvironment.

Disposed within housing 14 of the remote power console 12 areelectro-mechanical driver elements configured to drive the drive shafts30, 32 and the steering cables 34, 35, 36, 37 to thereby operate theelectro-mechanical surgical device 10 and the surgical instrument orattachment attached to the second coupling 26. In the example embodimentillustrated schematically in FIG. 6, five electric motors 76, 80, 84,90, 96, each operating via a power source, may be disposed in the remotepower console 12. It should be appreciated, however, that anyappropriate number of motors may be provided, and the motors may operatevia battery power, line current, a DC power supply, an electronicallycontrolled DC power supply, etc. It should also be appreciated that themotors may be connected to a DC power supply, which is in turn connectedto line current and which supplies the operating current to the motors.

FIG. 6 illustrates schematically one possible arrangement of motors. Anoutput shaft 78 of a first motor 76 engages with the first connector 44of the first coupling 22 when the first coupling 22, and, therefore,flexible shaft 20, is engaged with the housing 14 to thereby drive thefirst drive shaft 30 and first connector 66 of second coupling 26.Similarly, an output shaft 82 of a second motor 80 engages the secondconnector 48 of first coupling 22 when first coupling 22, and,therefore, flexible shaft 20 is engaged with the housing 14 to therebydrive the second drive shaft 32 and second connector 68 of secondcoupling 26. An output shaft 86 of a third motor 84 engages the thirdconnector 52 of the first coupling 22 when the first coupling 22, and,therefore, flexible shaft 20, is engaged with the housing 14 to therebydrive the first and second steering cables 34, 35 via a first pulleyarrangement 88. An output shaft 92 of a fourth motor 90 engages thefourth connector 56 of the first coupling 22 when the first coupling 22,and, therefore, flexible shaft 20, is engaged with the housing 14 tothereby drive the third and fourth steering cables 36, 37 via a secondpulley arrangement 94. The third and fourth motors 84, 90 may be securedon a carriage 100, which is selectively movable via an output shaft 98of a fifth motor 96 between a first position and a second position toselectively engage and disengage the third and fourth motors 84, 90 withthe respective pulley arrangement 88, 94 to thereby permit the flexibleshaft 20 to become taut and steerable or limp as necessary. It should beappreciated that other mechanical, electrical or electro-mechanicalmechanisms may be used to selectively engage and disengage the steeringmechanism. The motors may be arranged and configured as described, forexample, in U.S. patent application Ser. No. 09/510,923, entitled “ACarriage Assembly for Controlling a Steering Wire Mechanism Within aFlexible Shaft,” which is expressly incorporated herein in its entiretyby reference thereto.

It should be appreciated, that any one or more of the motors 76, 80, 84,90, 96 may be high-speed/low-torque motors or low-speed/high-torquemotors. As indicated above, the first rotatable drive shaft 30 and thesecond rotatable drive shaft 32 may be configured to transmit high speedand low torque. Thus, the first motor 76 and the second motor 80 may beconfigured as high-speed/low-torque motors. Alternatively, the firstmotor 76 and the second motor 80 may be configured aslow-speed/high-torque motors with a torque-reducing/speed-increasinggear arrangement disposed between the first motor 76 and the secondmotor 80 and a respective one of the first rotatable drive shaft 30 andthe second rotatable drive shaft 32. Suchtorque-reducing/speed-increasing gear arrangement may include, forexample, a spur gear arrangement, a planetary gear arrangement, aharmonic gear arrangement, cycloidal drive arrangement, an epicyclicgear arrangement, etc. It should be appreciated that any such geararrangement may be disposed within the remote power console 12 or in theproximal end of the flexible shaft 20, such as, for example, in thefirst coupling 22. It should be appreciated that the gear arrangement(s)are provided at the distal and/or proximal ends of the first rotatabledrive shaft 30 and/or the second rotatable drive shaft 32 to preventwindup and breakage thereof.

Referring now to FIG. 7, there is seen a schematic view of theelectro-mechanical surgical device 10. A controller 122 is provided inthe housing 14 of remote power console 12 and is configured to controlall functions and operations of the electro-mechanical surgical device10 and any surgical instrument or attachment attached to the flexibleshaft 20. A memory unit 130 is provided and may include memory devices,such as, a ROM component 132 and/or a RAM component 134. ROM component132 is in electrical and logical communication with controller 122 vialine 136, and RAM component 134 is in electrical and logicalcommunication with controller 122 via line 138. RAM component 134 mayinclude any type of random-access memory, such as, for example, amagnetic memory device, an optical memory device, a magneto-opticalmemory device, an electronic memory device, etc. Similarly, ROMcomponent 132 may include any type of read-only memory, such as, forexample, a removable memory device, such as a PC-Card or PCMCIA-typedevice. It should be appreciated that ROM component 132 and RAMcomponent 134 may be embodied as a single unit or may be separate unitsand that ROM component 132 and/or RAM component 134 may be provided inthe form of a PC-Card or PCMCIA-type device. Controller 122 is furtherconnected to front panel 15 of housing 14 and, more particularly, todisplay device 16 via line 154 and indicators 18 a, 18 b via respectivelines 156, 158. Lines 116, 118, 124, 126, 128 electrically and logicallyconnect controller 122 to first, second, third, fourth and fifth motors76, 80, 84, 90, 96, respectively. A wired remote control unit (“RCU”)150 is electrically and logically connected to controller 122 via line152. A wireless RCU 148 is also provided and communicates via a wirelesslink 160 with a receiving/sending unit 146 connected via line 144 to atransceiver 140. The transceiver 140 is electrically and logicallyconnected to controller 122 via line 142. Wireless link 160 may be, forexample, an optical link, such as an infrared link, a radio link or anyother form of wireless communication link.

A switch device 186, which may be, for example, an array of DIPswitches, may be connected to controller 122 via line 188. Switch device186 may be used, for example, to select one of a plurality of languagesused in displaying messages and prompts on the display device 16. Themessages and prompts may relate to, for example, the operation and/orthe status of the electro-mechanical surgical device 10 and/or to anysurgical instrument or attachment attached thereto,

According to the example embodiment of the present invention, a firstencoder 106 is provided within the second coupling 26 and is configuredto output a signal in response to and in accordance with the rotation ofthe first drive shaft 30. A second encoder 108 is also provided withinthe second coupling 26 and is configured to output a signal in responseto and in accordance with the rotation of the second drive shaft 32. Thesignal output by each of the encoders 106, 108 may represent therotational position of the respective drive shaft 30, 32 as well as therotational direction thereof. Such encoders 106, 108 may be, forexample, Hall-effect devices, optical devices, etc. Although theencoders 106, 108 are described as being disposed within the secondcoupling 26, it should be appreciated that the encoders 106, 108 may beprovided at any location between the motor system and the surgicalinstrument or attachment. It should be appreciated that providing theencoders 106, 108 within the second coupling 26 or at the distal end ofthe flexible shaft 20 provides for an accurate determination of thedrive shaft rotation. If the encoders 106, 108 are disposed at theproximal end of the flexible shaft 20, windup of the first and secondrotatable drive shafts 30, 32 may result in measurement error.

FIG. 8 is a schematic view of an encoder 106, 108, which includes aHall-effect device. Mounted non-rotatably on drive shaft 30, 32 is amagnet 240 having a north pole 242 and a south pole 244. The encoder106, 108 further includes a first sensor 246 and second sensor 248,which are disposed approximately 90° apart relative to the longitudinal,or rotational, axis of drive shaft 30, 32. The output of the sensors246, 248 is persistent and changes its state as a function of a changeof polarity of the magnetic field in the detection range of the sensor.Thus, based on the output signal from the encoders 106, 108, the angularposition of the drive shaft 30, 32 may be determined within one-quarterrevolution and the direction of rotation of the drive shaft 30, 32 maybe determined. The output of each encoder 106, 108 is transmitted via arespective line 110, 112 of data transfer cable 38 to controller 122.The controller 122, by tracking the angular position and rotationaldirection of the drive shafts 30, 32 based on the output signal from theencoders 106, 108, can thereby determine the position and/or state ofthe components of the surgical instrument or attachment connected to theelectro-mechanical surgical device 10. That is, by counting therevolutions of the drive shaft 30, 32, the controller 122 can determinethe position and/or state of the components of the surgical instrumentor attachment connected to the electro-mechanical surgical device 10.

For example, in a circular surgical stapler attachment 250, such as thatshown schematically in cross-section in FIG. 9 a, the circular surgicalstapler attachment 250 includes a coupling 260 adapted by size andconfiguration to cooperate with the second coupling 26 of flexible shaft20 to detachably attach the circular surgical stapler attachment 250thereto. Circular surgical stapler attachment 250 includes an anvilportion 254 having an anvil 256 mounted on the distal end of an anvilstem 258. The anvil stem 258 is extended and retracted by the operationof an anvil drive shaft 262, which is rotatably secured within the bodyportion 252 of the circular surgical stapler attachment 250. A proximalend of the anvil drive shaft 262 includes a first connector 268 adaptedby size and configuration to couple with the first connector 66 ofsecond coupling 26. Circular surgical stapler attachment 250 furtherincludes a staple driver/cutter 264 driven by the rotation of a stapledriver/cutter drive shaft 266. The proximal end of the stapledriver/cutter drive shaft 266 includes a second connector 270, which isadapted by size and configuration to couple with the second connector 68of second coupling 26.

The extension and retraction of the anvil 256 is effected by theoperation of the first motor 76, and the extension and retraction of thestaple driver/cutter 264 is effected by the operation of the secondmotor 80. The pitch of the anvil drive shaft 262 and the pitch of thestapler driver/cutter drive shaft 266 are predetermined and knownquantities. That is, the advancement distance of the anvil 256 and thestaple driver/cutter 264 are functions of, and ascertainable on thebasis of, the rotation of the respective drive shaft 30, 32. Byascertaining an absolute position of the anvil 256 and the stapledriver/cutter 264 at a point in time, the relative displacement of theanvil 256 and staple driver/cutter 264, based on the output signal fromthe encoders 106, 108 and the known pitches of the anvil drive shaft 262and staple driver/cutter drive shaft 266, may be used to ascertain theabsolute position of the anvil 256 and staple driver/cutter 264 at alltimes thereafter. The absolute position of the anvil 256 and stapledriver/cutter 264 may be fixed and ascertained at the time that thecircular surgical stapler attachment 250 is first coupled to theflexible shaft 20. Alternatively, the position of the anvil 256 and thestaple driver/cutter 264 relative to, for example, the body portion 252may be determined based on the output signal from the encoders 106, 108.

Circular surgical stapler attachment 250 further includes a dataconnector 272 adapted by size and configuration to electrically andlogically connect to connector 70 of second coupling 26. In the exampleembodiment, data connector 272 includes contacts (not shown) equal innumber to the number of leads 72 of connector 70.

Contained within the circular surgical stapler attachment 250 is amemory unit 174 electrically and logically connected with the dataconnector 272. Memory unit 174 may be in the form of, for example, anEEPROM, EPROM, etc. and may be contained, for example, within the bodyportion 252 of circular surgical stapler attachment 250.

FIG. 9 b is a schematic cross-sectional view of a second exampleembodiment of a circular surgical stapler attachment 2250. The circularsurgical stapler attachment 2250 includes a coupling 2260 adapted bysize and configuration to cooperate with the second coupling 26 offlexible shaft 20 to detachably attach the circular surgical staplerattachment 2250 thereto. Circular surgical stapler attachment 2250includes an anvil portion 2254 having an anvil 2256 mounted on thedistal end of an anvil stem 2258. The anvil stem 2258 may be detachablysecured to a trocar 2274. The anvil stem 2258 is extended and retractedby the operation of an anvil drive shaft 2262, which is rotatablysecured within the body portion 2252 of the circular surgical staplerattachment 2250. The anvil drive shaft 2262 may be externally threaded,and the trocar 2274 may be internally threaded at the proximal end 2276thereof so that rotation of the anvil drive shaft 2262 causes theextension and retraction of the anvil stem 2262. A proximal end of theanvil drive shaft 2262 includes a first connector 2268 adapted by sizeand configuration to couple with the first connector 66 of secondcoupling 26. Circular surgical stapler attachment 2250 further includesa staple driver/cutter 2264, which is driven by the rotation of a stapledriver/cutter drive shaft 2266. The proximal end of the stapledriver/cutter drive shaft 2266 includes a second connector 2270, whichis adapted by size and configuration to couple with the second connector68 of the second coupling 26. A gearing arrangement 2278 is disposedbetween the staple driver/cutter drive shaft 2266 and the stapledriver/cutter 2264. The gearing arrangement 2278 may include, forexample, a planetary gear arrangement, a harmonic gear arrangement,cycloidal drive arrangement, an epicyclic gear arrangement, etc., whichis configured to convert the high-speed/low-torque transmitted by thesecond rotating drive shaft 32 to low-speed/high-torque for ejecting andforming the staples, as more fully described herein. FIG. 9 c is anexploded view of the gearing arrangement 2278, which includes aplanetary gear arrangement, namely four sets of planetary gears 2280 a,2280 b, 2280 c, 2280 d. The operation of the second example embodimentof the circular surgical stapler attachment 2250 is similar to theoperation of the first example embodiment of the circular surgicalstapler attachment 250 as more fully set forth above.

FIG. 10 schematically illustrates the memory unit 174. As seen in FIG.10, data connector 272 includes contacts 276, each electrically andlogically connected to memory unit 174 via a respective line 278. Memoryunit 174 is configured to store, for example, a serial number data 180,an attachment type identifier (ID) data 182 and a usage data 184. Memoryunit 174 may additionally store other data. Both the serial number data180 and the ID data 182 may be configured as read-only data. In theexample embodiment, serial number data 180 is data uniquely identifyingthe particular surgical instrument or attachment, whereas the ID data182 is data identifying the type of the attachment, such as, forexample, a circular surgical stapler attachment, a linear surgicalstapler attachment, etc. The usage data 184 represents usage of theparticular attachment, such as, for example, the number of times theanvil 256 of the circular surgical stapler attachment 250 has beenadvanced or the number of times that the staple driver/cutter 264 of thecircular surgical stapler attachment 250 has been advanced or fired.

It should be appreciated that each type of surgical instrument orattachment attachable to the distal end 24 of the flexible shaft 20 maybe designed and configured to be used a single time or multiple times.The surgical instrument or attachment may also be designed andconfigured to be used a predetermined number of times. Accordingly, theusage data 184 may be used to determine whether the surgical instrumentor attachment has been used and whether the number of uses has exceededthe maximum number of permitted uses. As more fully described below, anattempt to use a surgical instrument or attachment after the maximumnumber of permitted uses has been reached will generate an ERRORcondition.

It should be appreciated that the circular surgical stapler attachment250 illustrated in FIG. 9 a is intended to be merely an example of asurgical attachment used in conjunction with the electro-mechanicalsurgical device 10. It should be further appreciated that any other typeof surgical instrument or attachment, such as those enumeratedhereinabove, may be used in conjunction with the electro-mechanicalsurgical device 10. Regardless of the particular type of surgicalinstrument or attachment, in the example embodiment of the presentinvention, the surgical instrument or attachment includes the couplingelements 268, 270, 272, as necessary for proper operation of thesurgical instrument or attachment, as well as the memory unit 174.Although the drive shafts and motors are described herein as effectingparticular functions of the circular surgical stapler attachment 250, itshould be appreciated that the drive shafts and motors may effect thesame or other functions of other types of surgical instruments orattachments.

Referring again to FIG. 7, in accordance with the example embodiment ofthe present invention, the controller 122 is configured to read the IDdata 182 from the memory unit 174 of the surgical instrument orattachment when the surgical instrument or attachment is initiallyconnected to the flexible shaft 20, and the controller 122 is configuredto read the ID data 880 from the memory unit 850 of the PCB 635 of thesecond coupling 26. The memory units 174, 850 may be electrically andlogically connected in parallel to the controller 122 via line 120 ofdata transfer cable 38 or, alternatively, may be connected to thecontroller 122 via respective dedicated lines.

Based on the read usage data 870 of the flexible shaft 20, thecontroller 122 may prevent the surgical device 10 from driving theflexible shaft 20. As described above, a particular flexible shaft 20may be designed and configured to be used a single time, multiple times,or a predetermined number of times. Accordingly, the usage data 870 maybe read by the controller 122 to determine whether the flexible shaft 20has been used and whether the number of uses has exceeded a maximumnumber of permitted uses. If the maximum number of uses has beenexceeded, the controller 122 may prevent subsequent attempts to use theflexible shaft 20.

Additionally, the controller 122 may write the usage data 870 to thememory unit 850 of the flexible shaft 20. The written usage data 870 mayinclude information relating to, for example, a number of revolutions ofone or both rotatable drive shafts 30, 32, a number of uses of one orboth rotatable drive shafts 30, 32, a number of firings of one or bothrotatable drive shafts 30, 32, and/or the number of times the flexibleshaft 20 has been used, etc. It should be appreciated that the writtenusage data 870 may include information in any form suitable to indicatea change in any condition of the flexible shaft 20 that may relate, forexample, to usage.

Based on the read ID data 182, the controller 122 is configured to reador select from the memory unit 130, an operating program or algorithmcorresponding to the type of surgical instrument or attachment connectedto the flexible shaft 20. The memory unit 130 is configured to store theoperating programs or algorithms for each available type of surgicalinstrument or attachment, the controller 122 selecting and/or readingthe operating program or algorithm from the memory unit 130 inaccordance with the ID data 182 read from the memory unit 174 of anattached surgical instrument or attachment. As indicated above, thememory unit 130 may include a removable ROM component 132 and/or RAMcomponent 134. Thus, the operating programs or algorithms stored in thememory unit 130 may be updated, added, deleted, improved or otherwiserevised as necessary. The operating programs or algorithms stored in thememory unit 130 may be customizable based on, for example, specializedneeds of the user. A data entry device, such as, for example, akeyboard, a mouse, a pointing device, a touch screen, etc., may beconnected to the memory unit 130 via, for example, a data connectorport, to facilitate the customization of the operating programs oralgorithms. Alternatively or additionally, the operating programs oralgorithms may be customized and preprogramed into the memory unit 130remotely from the electro-mechanical surgical device 10. It should beappreciated that the serial number data 180 and/or usage data 184 mayalso be used to determine which of a plurality of operating programs oralgorithms is read or selected from the memory unit 130. It should beappreciated that the operating program or algorithm may alternatively bestored in the memory unit 174 of the surgical instrument or attachmentand transferred to the controller 122 via the data transfer cable 38.Once the appropriate operating program or algorithm is read or selectedby, or transmitted to, the controller 122, the controller 122 causes theoperating program or algorithm to be executed in accordance withoperations performed by the user via the wired RCU 150 and/or thewireless RCU 148. As indicated hereinabove, the controller 122 iselectrically and logically connected with the first, second, third,fourth and fifth motors 76, 80, 84, 90, 96 via respective lines 116,118, 124, 126, 128 and controls such motors 76, 80, 84, 90, 96 inaccordance with the read, selected or transmitted operating program oralgorithm via the respective lines 116, 118, 124, 126, 128.

Referring now to FIG. 11, there is seen a schematic view of wireless RCU148. Wireless 148 includes a steering controller 300 having a pluralityof switches 302, 304, 306, 308 arranged under a four-way rocker 310. Theoperation of switches 302, 304, via rocker 310, controls the operationof first and second steering cables 34, 35 via third motor 84.Similarly, the operation of switches 306, 308, via rocker 310, controlsthe operation of third and fourth steering cables 36, 37 via fourthmotor 92. It should be appreciated that rocker 310 and switches 302,304, 306, 308 are arranged so that the operation of switches 302, 304steers the flexible shaft 20 in the north-south direction and that theoperation of switches 306, 308 steers the flexible shaft 20 in theeast-west direction. Reference herein to north, south, east and west ismade to a relative coordinate system. Alternatively, a digital joystick,analog joystick, etc. may be provided in place of rocker 310 andswitches 302, 304, 306, 308. Potentiometers or any other type ofactuator may also be used in place of switches 302, 304, 306, 308.

Wireless RCU 148 further includes a steering engage/disengage switch312, the operation of which controls the operation of fifth motor 96 toselectively engage and disengage the steering mechanism. Wireless RCU148 also includes a two-way rocker 314 having first and second switches316, 318 operable thereby. The operation of these switches 316, 318controls certain functions of the electro-mechanical surgical device 10and any surgical instrument or attachment attached to the flexible shaft20 in accordance with the operating program or algorithm correspondingto the attached surgical instrument or attachment, if any. For example,where the surgical instrument is a circular surgical stapler attachment250, such as that shown in FIG. 9 a and described hereinabove, operationof the two-way rocker 314 may control the advancement and retraction ofthe anvil 256. Wireless RCU 148 is provided with yet another switch 320,the operation of which may further control the operation of theelectro-mechanical surgical device 10 and any surgical instrument orattachment attached to the flexible shaft 20 in accordance with theoperating program or algorithm corresponding to the attached surgicalinstrument or attachment, if any. For example, when the circularsurgical stapler attachment 250 is attached to the flexible shaft 20,operation of the switch 320 initiates the advancement, or firingsequence, of the staple driver/cutter 264.

Wireless RCU 148 includes a controller 322, which is electrically andlogically connected with the switches 302, 304, 306, 308 via line 324,with the switches 316, 318 via line 326, with switch 312 via line 328and with switch 320 via line 330. Wireless RCU 148 may includeindicators 18 a′, 18 b′, corresponding to the indicators 18 a, 18 b offront panel 15, and a display device 16′, corresponding to the displaydevice 16 of the front panel 15. If provided, the indicators 18 a′, 18b′ are electrically and logically connected to controller 322 viarespective lines 332, 334, and the display device 16′ is electricallyand logically connected to controller 322 via line 336. Controller 322is electrically and logically connected to a transceiver 338 via line340, and transceiver 338 is electrically and logically connected to areceiver/transmitter 342 via line 344. A power supply, not shown, forexample, a battery, may be provided in wireless RCU 148 to power thesame. Thus, the wireless RCU 148 may be used to control the operation ofthe electro-mechanical surgical device 10 and any surgical instrument orattachment attached to the flexible shaft 20 via wireless link 160.

Wireless RCU 148 may include a switch 346 connected to controller 322via line 348. Operation of switch 346 transmits a data signal to thetransmitter/receiver 146 via wireless link 160. The data signal includesidentification data uniquely identifying the wireless RCU 148. Thisidentification data is used by the controller 122 to preventunauthorized operation of the electro-mechanical surgical device 10 andto prevent interference with the operation of the electro-mechanicalsurgical device 10 by another wireless RCU. Each subsequentcommunication between the wireless RCU 148 and the electro-mechanicaldevice surgical 10 may include the identification data. Thus, thecontroller 122 can discriminate between wireless RCUs and thereby allowonly a single, identifiable wireless RCU 148 to control the operation ofthe electro-mechanical surgical device 10 and any surgical instrument orattachment attached to the flexible shaft 20.

Based on the positions of the components of the surgical instrument orattachment attached to the flexible shaft 20, as determined inaccordance with the output signals from the encoders 106, 108, thecontroller 122 may selectively enable or disable the functions of theelectro-mechanical surgical device 10 as defined by the operatingprogram or algorithm corresponding to the attached surgical instrumentor attachment. For example, where the surgical instrument or attachmentis the circular surgical stapler attachment 250 illustrated in FIG. 9 a,the firing function controlled by the operation of the switch 320 isdisabled unless the space or gap between the anvil 256 and the bodyportion 252 is determined to be within an acceptable range. The space orgap between the anvil 256 and the body portion 252 is determined basedon the output signal from the encoders 106, 108, as more fully describedhereinabove. It should be appreciated that the switch 320 itself remainsoperable but that the controller 122 does not effect the correspondingfunction unless the space or gap is determined to be within theacceptable range.

Referring now to FIG. 12, there is seen a schematic view of a wired RCU150. In the example embodiment, wired RCU 150 includes substantially thesame control elements as the wireless RCU 148 and further description ofsuch elements is omitted. Like elements are noted in FIG. 12 with anaccompanying prime. It should be appreciated that the functions of theelectro-mechanical surgical device 10 and any surgical instrument orattachment attached to the flexible shaft 20 may be controlled by thewired RCU 150 and/or by the wireless RCU 148. In the event of a batteryfailure, for example, in the wireless RCU 148, the wired RCU 150 may beused to control the functions of the electro-mechanical surgical device10 and any surgical instrument or attachment attached to the flexibleshaft 20.

As described hereinabove, the front panel 15 of housing 14 includesdisplay device 16 and indicators 18 a, 18 b. The display device 16 mayinclude an alpha-numeric display device, such as an LCD display device.Display device 16 may also include an audio output device, such as aspeaker, a buzzer, etc. The display device 16 is operated and controlledby controller 122 in accordance with the operating program or algorithmcorresponding to a surgical instrument or attachment, if any, attachedto the flexible shaft 20. If no surgical instrument or attachment is soattached, a default operating program or algorithm may be read orselected by, or transmitted to, controller 122 to thereby control theoperation of the display device 16 as well as the other aspects andfunctions of the electro-mechanical surgical device 10. If the circularsurgical stapler attachment 250 illustrated in FIG. 9 a is attached toflexible shaft 20, display device 16 may display, for example, dataindicative of the gap between the anvil 256 and the body portion 252 asdetermined in accordance with the output signal of encoders 106, 108, asmore fully described hereinabove.

Similarly, the indicators 18 a, 18 b are operated and controlled bycontroller 122 in accordance with the operating program or algorithmcorresponding to the surgical instrument or attachment, if any, attachedto the flexible shaft 20. Indicator 18 a and/or indicator 18 b mayinclude an audio output device, such as a speaker, a buzzer, etc.,and/or a visual indicator device, such as an LED, a lamp, a light, etc.If the circular surgical stapler attachment 250 illustrated in FIG. 9 ais attached to the flexible shaft 20, indicator 18 a may indicate, forexample, that the electro-mechanical surgical device 10 is in a power ONstate, and indicator 18 b may, for example, indicate whether the gapbetween the anvil 256 and the body portion 252 is determined to bewithin the acceptable range as more fully described hereinabove. Itshould be appreciated that although only two indicators 18 a, 18 b aredescribed, any number of additional indicators may be provided asnecessary. Additionally, it should be appreciated that although a singledisplay device 16 is described, any number of additional display devicesmay be provided as necessary.

The display device 16′ and indicators 18 a′, 18 b′ of wireless RCU 150and the display device 16″ and indicators 18 a″, 18 b″ of wired RCU 148are similarly operated and controlled by respective controller 322, 322′in accordance with the operating program or algorithm corresponding tothe surgical instrument or attachment, if any, attached to the flexibleshaft 20.

Referring now to FIG. 13, there is seen a flowchart of a first exampleembodiment of a main operating program according to the presentinvention. The main operating program begins at step 1000 and proceedsto step 1002, during which the electro-mechanical surgical device 10 isinitialized. Step 1002 may include initialization steps, such as memorypopulation and initialization, diagnostic self-testing, etc. Afterinitialization step 1002, it is determined in step 1004 whether asurgical instrument or attachment (“DLU”) is present—that is, installedon the distal end 24 of flexible shaft 20. If it is determined in step1004 that no DLU is present, control is transferred to loop 1034. If itis determined that a DLU is present, the operating program proceeds tostep 1006, in which it is determined whether the FIRE key is pressed.FIRE key, in this context, refers to one of the switches of the wirelessRCU 148 and/or wired RCU 150. More particularly, the FIRE key maycorrespond to switch 320 of wireless RCU 148 and/or switch 320′ of wiredRCU 150. If it is determined in step 1006 that FIRE key is pressed,control is transferred to routine A in step 1008. Routine A is specificto the DLU, if any, attached to the flexible shaft 20. Routine A is morefully described hereinbelow and in FIGS. 14 a to 14 d. After theexecution of routine A in step 1008, control is transferred to loop1034.

If it is determined in step 1006 that the FIRE key is not pressed, it isdetermined in step 1010 whether the CLAMP key is pressed. In thiscontext, the CLAMP key refers to one of the switches of the wireless RCU148 and/or wired RCU 150. More particularly, CLAMP switch may correspondto, for example, switch 316 of wireless RCU 148 and/or to switch 316′ ofwired RCU 150. If it is determined in step 1010 that CLAMP key ispressed, control is transferred to routine B in step 1012. Routine B isspecific to the DLU, if any, attached to the flexible shaft 20. RoutineB is more fully described hereinbelow and in FIGS. 15 a and 15 b. Afterthe execution of routine B in step 1012, control is transferred to loop1034.

If it is determined in step 1010 that the CLAMP key is not pressed, itis determined in step 1014 whether the UNCLAMP key is pressed. In thiscontext, the UNCLAMP key refers to one of the switches of the wirelessRCU 148 and/or wired RCU 150. More particularly, the UNCLAMP switch maycorrespond to, for example, switch 318 of wireless RCU 148 and/or toswitch 318′ of wired RCU 150. If it is determined in step 1014 thatUNCLAMP key is pressed, control is transferred to routine C in step1016. Routine C is specific to the DLU, if any, attached to the flexibleshaft 20. Routine C is more fully described hereinbelow and in FIG. 16.After the execution of routine C in step 1016, control is transferred toloop 1034.

If it is determined in step 1014 that the UNCLAMP key is not pressed, itis determined in step 1018 whether one or more of STEERING keys arepressed. In this context, the STEERING keys refer to respective switchesof the wireless RCU 148 and/or wired RCU 150. More particularly, theSTEERING keys may correspond to switches 302, 304, 306, 308 of wirelessRCU 148 and/or switches 302′, 304′, 306′, 308′ of wired RCU 150. If itis determined in step 1018 that one or more STEERING keys are pressed,operation of respective steering motor(s) is performed in step 1020. Thesteering motors may correspond to third motor 84 and fourth motor 92 asmore fully set forth above. After the execution of step 1020, control istransferred to loop 1034.

If it is determined in step 1018 that none of the STEERING keys ispressed, it is determined in step 1022 whether the DISENGAGE key ispressed. In this context, the DISENGAGE key refers to one of theswitches of wireless RCU 148 and/or wired RCU 150. More particularly,DISENGAGE key may correspond to switch 312 of wireless RCU 148 and/orswitch 312′ of wired RCU 150. If it is determined in step 1022 that theDISENGAGE key is pressed, a disengage operation is performed in step1024. After the execution of step 1024, control is transferred to loop1034.

If it is determined in step 1022 that DISENGAGE key is not pressed, anIDLE routine is performed in step 1026.

In step 1028, it is determined whether to end the operation of the mainoperating program. If it is determined in step 1028 to not end theoperation of the main operating program, control is transferred to loop1034. If, however, it is determined in step 1028 to end or terminate theoperation of the main operating program, a shutdown routine is executedin step 1030, and the main operating program is thereafter terminated instep 1032.

It should be appreciated that the main operating program may determinewhich, if any, key is pressed in the order illustrated in FIG. 13 or inany other appropriate order. It should also be appreciated that the mainoperating program illustrated in FIG. 13, as well as the routinesillustrated in FIGS. 14 a to 14 d, 15 a, 15 b and 16, may be embodied,for example, in a messaging-based, event-driven and/or polling-typesoftware application.

Referring now to FIGS. 14 a to 14 d, there is seen a flowchart of afirst example embodiment of a fire routine specific to a circularsurgical stapler attachment 250, such as that illustrated in FIG. 9 a,or 2250, such as that illustrated in FIGS. 9 b and 9 c. It should beappreciated that the fire routine illustrated in FIGS. 14 a to 14 drepresents the routine A of step 1008 of the main operating programillustrated in FIG. 13 and that the firing routine illustrated in FIGS.14 a to 14 d is specific to a circular surgical stapler attachment 250,such as that illustrated in FIG. 9 a, or 2250, such as that illustratedin FIGS. 9 b and 9 c. It should be further appreciated that othersurgical instruments or attachments, such as those enumerated above, mayhave other firing routines associated therewith.

Proceeding from step 1008, it is determined in step 1100 whether theDLU—the circular surgical stapler attachment 250—has been fully opened.This determination may be made based on the signals generated by theencoders 106, 108, as more fully described above. If it is determined instep 1100 that the DLU has not been fully opened, an ERROR condition isdetermined in step 1102 in that the DLU is not ready for firing. Controlis then transferred to step 1120, wherein control returns to the mainoperating program illustrated in FIG. 13.

If it is determined in step 1100 that the DLU has been fully opened, itis determined in step 1104 whether the DLU has been fully clamped. Thisdetermination may be made based on the signals generated by the encoders106, 108, as more fully described above. If it is determined in step1104 that the DLU has not been fully clamped, an ERROR condition isdetermined in step 1106 in that the DLU is not within an acceptablerange for firing. Control is then transferred to step 1120, whereincontrol returns to the main operating program illustrated in FIG. 13.

If it is determined in step 1104 that the DLU has been fully clamped, itis determined in step 1108 whether the DLU has been previously fired.This determination may be made based on the signals generated by theencoders 106, 108 and/or in accordance with usage data 184. If it isdetermined in step 1108 that the DLU has been previously fired, an ERRORcondition is determined in step 1110 in that the DLU has been used.Control is then transferred to step 1120, wherein control returns to themain operating program illustrated in FIG. 13. It should be appreciatedthat a similar usage determination may be made in the main operatingprogram illustrated in FIG. 13, for example, in the initialization step1002 or in the DLU presence determining step 1004, as an alternative orin addition to the determining step 1108.

If it is determined in step 1108 that the DLU has not been previouslyfired, a usage count is decremented in step 1112. The usage count may bestored in usage data 184 as more fully described hereinabove. Severalattempts at decrementing the usage count may be made in step 1112.However, a failure to decrement the usage count may nevertheless occur.In step 1114, it is determined whether the usage count decrementing step1112 has failed. If it is determined in step 1114 that the decrementingof usage count failed, a ERROR condition is determined in step 1116.Thereafter, in step 1118, a wait loop is executed until all keys of thewireless RCU 148 and/or wired RCU 150 have been released. After it isdetermined in step 1118 that all keys have been released, control istransferred to step 1120. Thereafter, control returns to the mainoperating program illustrated in FIG. 13.

If it is determined in step 1114 that the usage count decrementing didnot fail, the firing motor current limit is set in step 1122. In thiscontext, the firing motor may correspond to the second motor 80 as morefully described hereinabove. The firing motor is then started in step1124 to begin the advancement of the staple driver/cutter 264.

Referring now to FIG. 14 b, a timer is set in step 1126. It isthereafter determined in step 1128 whether the time elapsed for thefiring operation has exceeded a predetermined threshold. If it isdetermined in step 1128 that the firing time limit has been exceeded,the firing motor is disabled in step 1130, and an ERROR condition isdetermined in step 1132. Control then proceeds to step 1136. If,however, it is determined in step 1128 that the firing time has notexceeded the predetermined firing time limit, it is determined in step1134 whether a hardware current limit has been exceeded. The hardwarecurrent limit relates to the resistance of the firing motor to continuedoperation. A condition that the hardware current limit has been exceededis indicative that the stapling operation has been successfullycompleted. If it is determined in step 1134 that the hardware currentlimit has not been exceeded, the operation of firing motor is continueduntil either the predetermined firing time limit has been exceeded orthe hardware current limit has been exceeded. In either instance controlproceeds thereafter to step 1136.

Step 1136 represents a waiting step, during which a predetermined waittime is permitted to elapse. This wait time permits the driving anddriven elements of electro-mechanical surgical device 10 and circularsurgical stapler attachment 250 to come to rest before proceeding tostep 1138, in which step the firing motor is stopped.

After the firing motor is stopped in step 1138, the motor current limitis set to full scale in step 1140, and then the firing motor is startedin step 1142 in a reverse direction to retract the staple driver/cutter264 and return the same to its initial position. Then, once the gapbetween the anvil 256 and the body portion 252 has exceeded theacceptable range, the indicator 18 a, 18 b corresponding to an IN-RANGEindicator is turned off in step 1144. Alternatively, the IN-RANGEindicator may be turned off in step 1144 upon the start of the reversalof the motor in step 1142. After the IN-RANGE indicator is turned off instep 1144, the timer is reset in step 1146.

Referring now to FIG. 14 c, it is determined in step 1148 whether apredetermined time limit for completing the retraction of the stapledriver/cutter 264, based on the timer reset in step 1146, has beenexceeded. If it is determined in step 1148 that the predetermined timelimit has been exceeded, an ERROR condition is determined in step 1150in that the retraction operation failed to be completed within thepermissible predetermined time limit. If, however, it is determined instep 1148 that the predetermined time limit has not been exceeded, it isdetermined in step 1152 whether retraction of the staple driver/cutter264 has been completed. If it is determined in step 1152 that theretraction of the staple driver/cutter 264 has not been completed,control returns to step 1148. Retraction of staple driver/cutter 264continues until either the predetermined time limit has been exceeded asdetermined in step 1148 or the retraction has been completed asdetermined in step 1152. It should be appreciated that the determinationmade in step 1152 may be based on the signals generated by the encoders106, 108. After it is determined that the retraction of stapledriver/cutter 264 has been completed (step 1152) or that thepredetermined time limit has been exceeded (step 1148), the unclampmotor current limit is set of full scale in step 1154. In this context,the unclamp motor may correspond to first motor 76 as more fullydescribed hereinabove.

In step 1156, the halfway point between the current position of theanvil 256 and the final, unclamped position of the anvil 256 iscalculated. A “phantom” destination position is set in step 1158 to apredetermined setpoint plus a predetermined bias value to ensure thatthe unclamp motor achieves its maximum, or full, current to therebyensure the maximum torque output from the unclamp motor. In step 1160,the movement of the unclamp motor is initiated. In step 1162, the timeris set, and in step 1164 a destination flag is cleared.

Referring now to FIG. 14 d, it is determined in step 1166 whether theanvil 256 has passed the halfway point determined in step 1156. If it isdetermined in step 1166 that the anvil 256 has passed the halfway pointdetermined in step 1156, the “true” final destination position for theanvil 256 is set in step 1170, thereby superceding the “phantom” finaldestination set in step 1158. Control is then transferred to step 1174.If, however, it is determined in step 1166 that the position of theanvil 256 is not past the halfway point determined in step 1156, controlis directly transferred to step 1174, bypassing the destinationresetting step 1170.

In step 1174, it is determined whether the anvil 256 has reached the“true” final destination set in step 1170. It should be appreciated thatthe position of the anvil 256 may be determined in accordance with thesignals output by encoders 106, 108 as more fully described hereinabove.If it is determined in step 1174 that anvil 256 has reached its “true”final destination set in step 1170, control is transferred to step 1180,described below. If, however, it is determined in step 1174 that the“true” final destination of the anvil 256 has not been reached, it isdetermined in step 1176, with reference to the timer reset in step 1162,whether a predetermined time limit has been exceeded. If it isdetermined in step 1176 that the predetermined time limit has not beenexceeded, control is returned to step 1166, and the unclamp motorcontinues its operation to further unclamp the anvil 256. If, however,it is determined in step 1176 that the predetermined time limit has beenexceeded, and ERROR condition is determined in step 1178 in that theanvil 256 could be moved into its “true” final destination within thepredetermined time limit. Control is thereafter transferred to step1180, in which the steering mechanism is disengaged. In the exampleembodiment of electro-mechanical surgical device 10 described above, thesteering mechanism may include the fifth motor 96 and/or carriage 100 asmore fully described hereinabove. After the steering mechanism has beendisengaged in step 1180, a wait loop is executed in step 1182 until allkeys of wireless RCU 148 and/or wired RCU 150 have been released. Onceall of the keys have been released, control returns in step 1184 to themain operating program illustrated in FIG. 13.

Referring now to FIGS. 15 a and 15 b, there is seen a flowchart of afirst example embodiment of a clamp routine specific to a circularsurgical stapler attachment 250, such as that illustrated in FIG. 9 a,or 2250, such as that illustrated in FIGS. 9 b and 9 c. It should beappreciated that the clamp routine illustrated in FIGS. 15 a and 15 brepresents the routine B of step 1012 of the main operating programillustrated in FIG. 13 and that the clamp routine illustrated in FIGS.15 a and 15 b is specific to a circular surgical stapler attachment 250,such as that illustrated in FIG. 9 a, or 2250, such as that illustratedin FIGS. 9 b and 9 c. It should be further appreciated that othersurgical instruments or attachments, such as those enumerated above, mayhave other clamping routines associated therewith.

Proceeding from step 1012, it is determined in step 1200 whether a DLUopen flag is set. If it is determined in step 1200 that the DLU openflag is not set, an ERROR condition is determined in step 1202 in thatthe DLU is not ready to clamp. A wait loop is executed thereafter instep 1204, and once all keys of wireless RCU 148 and/or wired RCU 150have been released, control returns in step 1206 to the main operatingprogram illustrated in FIG. 13.

If, however, it is determined in step 1200 that the DLU open flag isset, it is determined in step 1208 whether the gap between the anvil 256and the body portion 252 is greater than a predetermined threshold G₁,such as, for example, 5.0 mm. This determination may be made based onthe signals generated by the encoders 106, 108, as more fully describedabove. If it determined that the gap between the anvil 256 and the bodyportion 252 is less than the predetermined threshold G₁, controlproceeds to step 1220. If, however, it is determined in step 1208 thatthe gap between the anvil 256 and the body portion 252 is greater thanthe predetermined threshold G₁, control proceeds to step 1210 in which aCLAMP motor speed and torque limit are set to the respective maximumvalues. In this context, the CLAMP motor may correspond to first motor76 as more fully described hereinabove. A timer is reset in step 1212,and the control loop of steps 1214 and 1218 is executed until either apredetermined time period for reaching a gap of less than thepredetermined threshold G₁ is exceeded or the gap is determined to beless than the predetermined threshold G₁. If it is determined in step1214 that the predetermined time period has been exceeded, an ERRORcondition is determined in step 1216 in that the clamp operation isconsidered to have failed. After step 1216 is performed, step 1204 isperformed, in which a wait loop is executed until all keys of wirelessRCU 148 and/or wired RCU 150 have been released. Thereafter, controlreturns in step 1206 to the main operating program illustrated in FIG.13.

If it is determined in step 1214 that the predetermined time period hasnot been exceeded, it is determined in step 1218 whether the movement ofthe anvil 256 to a location in which the gap between the anvil 256 andthe body portion 252 is less than the predetermined threshold G₁ hasbeen completed. If it is determined in step 1218 that this move has notbeen completed, the operation of CLAMP motor is continued, and controlreturns to step 1214. If however, it is determined in step 1218 that themove is complete, control proceeds to step 1220.

In step 1220, a speed lower than the maximum speed set in step 1210 isset for the CLAMP motor and a torque limit lower than the torque limitset in step 1210 is set for the CLAMP motor. Thereafter, in step 1222, aposition bias is set to ensure that the CLAMP motor outputs full torquewhen the gap between the anvil 256 and the body portion 252 approachesthe bias value. The bias value may be, for example, approximately 1.0 mmto ensure full torque output from the CLAMP motor when the gap isapproximately equal to 1.0 mm.

Referring now to FIG. 15 b, control proceeds to step 1224, in which atimer is reset. In step 1226, the value of the current gap between theanvil 256 and the body portion 252 is displayed on the display device16. In step 1228, it is determined whether the gap between the anvil 256and the body portion 252 is less than a predetermined threshold G₂. Thisdetermination may be made based on the signals generated by the encoders106, 108, as more fully described above. The predetermined threshold G₂may be, for example, 2.0 mm. If the gap between the anvil 256 and thebody portion 252 is determined in step 1228 to be less than thepredetermined threshold G₂, control proceeds to step 1230, in which anIN-RANGE indicator is activated and a DLU ready flag is set. TheIN-RANGE indicator may correspond to one of the indicators 18 a, 18 b,either one or both of which may be, for example, LED elements or otheraudio or visual indicators. If it is determined in step 1228 that thegap between the anvil 256 and the body portion 252 is not less than thepredetermined threshold G₂, control proceeds to step 1232, in which itis determined whether the gap between the anvil 256 and the body portionis less than or equal to another predetermined threshold G₃. Thisdetermination may be made based on the signals generated by the encoders106, 108, as more fully described above. The predetermined threshold G₃may be, for example, 1.0 mm. If it is determined in step 1232 that thegap between the anvil 256 and the body portion 252 is less than or equalto the predetermined threshold G₃, control proceeds to step 1238,described below. However, if it is determined in step 1232 that the gapbetween the anvil 256 and the body portion 252 is greater than thepredetermined threshold G₃, it is determined in step 1234 whether thecurrent limit to the CLAMP motor has been reached for a predeterminedtime limit. That the current limit to the CLAMP motor has been reachedfor the predetermined time limit is indicative that tissue is fullyclamped between the anvil 256 and the body portion 252. Thepredetermined time limit may be, for example, 1.0 second. If it isdetermined in step 1234 that the current limit to the CLAMP motor hasbeen reached for the predetermined time limit, control proceeds to step1238. If, however, it is determined in step 1234 that the current limitto the CLAMP motor has not been exceeded for the predetermined timelimit, it is determined in step 1236 whether the CLAMP key has beenreleased. If it is determined in step 1236 that the CLAMP key has notbeen released, control returns to step 1226. If it is determined in step1236 that the CLAMP key has been released, control proceeds to step1238.

In step 1238, the operation of the CLAMP motor is stopped. Thereafter,in step 1240, a wait loop is executed until all keys of wireless RCU 148and/or wired RCU 150 have been released. After all keys have beenreleased, control returns in step 1242 to the main operating programillustrated in FIG. 13.

Referring now to FIG. 16, there is seen a flowchart of a first exampleembodiment of an unclamp routine specific to a circular surgical staplerattachment 250, such as that illustrated in FIG. 9 a, or 2250, such asthat illustrated in FIGS. 9 b and 9 c. It should be appreciated that theunclamp routine illustrated in FIG. 16 represents the routine C of step1016 of the main operating program illustrated in FIG. 13 and that theunclamp routine illustrated in FIG. 16 is specific to a circularsurgical stapler attachment 250, such as that illustrated in FIG. 9 a,or 2250, such as that illustrated in FIGS. 9 b and 9 c. It should befurther appreciated that other surgical instruments or attachments, suchas those enumerated above, may have other unclamp routines associatedtherewith.

Proceeding from step 1016, a torque limit for an UNCLAMP motor is set instep 1300 to its maximum value. The UNCLAMP motor may correspond to theCLAMP motor as more fully described hereinabove. The UNCLAMP motor mayalso correspond to the first motor 76 as more fully describedhereinabove.

In step 1302, the destination position for the anvil 256 is set to avalue representative of its fully unclamped position. The operation ofthe UNCLAMP motor is initiated in step 1304. In step 1306, it isdetermined whether the UNCLAMP key has been released. If it isdetermined in step 1306 that the UNCLAMP key has been released, controlproceeds to step 1314. If it is determined in step 1306 that the UNCLAMPkey has not been released, it is determined in step 1308 whether the gapbetween the anvil 256 and the body portion 252 is greater than or equalto a predetermined threshold G₄, which is defined in accordance with thedestination position set in step 1302. This determination may be madebased on the signals generated by the encoders 106, 108, as more fullydescribed above. If it is determined in step 1308 that the gap betweenthe anvil 256 and the body portion 252 is greater than or equal to thepredetermined threshold G₄, a DLU opened flag is set in step 1310.Control then proceeds to step 1312. If it is determined in step 1308that the gap between the anvil 256 and the body portion 252 is less thanthe predetermined threshold G₄, it is determined in step 1312 whetherthe unclamp operation is complete. That is, whether the destinationposition for the anvil 256 set in step 1302 has been reached. If it isdetermined in step 1312 that the movement of the anvil 256 is notcomplete, control returns to step 1306. If it is determined in step 1312that the movement of the anvil 256 is complete, the operation of theUNCLAMP motor is stopped in step 1314. Control then returns in step 1316to the main operating program illustrated in FIG. 13.

FIGS. 17 a to 17 d illustrate a flowchart of a second example embodimentof a main operating program for operating the electro-mechanicalsurgical device illustrated in FIG. 1. FIGS. 18 a and 18 b illustrate aflowchart of a self-test operating program for the electro-mechanicalsurgical device illustrated in FIG. 1. FIGS. 19 a to 19 e illustrate aflowchart for a field test operating program for the electro-mechanicalsurgical device illustrated in FIG. 1. FIGS. 20 a to 20 c illustrate aflowchart for a main operating program for operating the circularsurgical stapler attachment, such as that illustrated in FIGS. 9 a to 9c. FIGS. 21 a to 21 d illustrate a flowchart of a second exampleembodiment of a fire routine for a circular surgical stapler attachment,such as that illustrated in FIGS. 9 a to 9 c. FIGS. 22 a and 22 billustrate a flowchart of a second example embodiment of a clamp routinefor a circular surgical stapler attachment, such as that illustrated inFIGS. 9 a to 9 c. FIGS. 23 a and 23 b illustrate a flowchart of a secondexample embodiment of an unclamp routine for a circular surgical staplerattachment, such as that illustrated in FIGS. 9 a to 9 c. The operatingprograms illustrated in FIGS. 17 a to 23 b are readily understood bythose skilled in the art, and a further description thereof is notincluded herein.

It should be understood that the operation of the several motors andswitch elements as described above with respect to the circular surgicalstapler attachment 250, 2250 may be specific to the circular surgicalstapler attachment 250, 2250. The motor(s) and/or switch(es) may performother functions when other surgical instruments or attachments areattached to flexible shaft 20.

It should be appreciated that the surgical instrument or attachment,such as, for example, the circular surgical stapler attachment 250illustrated in FIG. 9 a or the circular surgical stapler attachment 2250illustrated in FIG. 9 b, may be configured to be attached to theflexible shaft 20 either extracorporally or intracorporally.Intracorporal attachment of the surgical instrument or attachment mayresult in, for example, reduced trauma and improved recovery time. Forexample, conventional linear cutter devices and linear stapler deviceshave been used to perform functional end-to-end anastomosis proceduresalong the intestinal tract. Due to the length, small diameter,flexibility and steerability of the flexible shaft 20, the flexibleshaft 20, without any surgical instrument or attachment attachedthereto, may be entered into the body, such as, for example, into togastrointestinal tract via the mouth or the rectum with minimal trauma.It should be appreciated that the flexible shaft 20 may be entered intothe body via, for example, a natural orifice, an incision, a cannula,etc. The flexible shaft 20 may then be further inserted into the bodyand steered, as more fully set forth above, so that the distal end 24 ofthe flexible shaft 20 is delivered to the treatment site, such as, forexample, along the intestinal tract. Then, after the distal end 24 ofthe flexible shaft 20 has been delivered to the treatment side, thesurgical instrument or attachment is attached to the flexible shaft 20via the second coupling 26 in situ. The surgical instrument orattachment may be inserted into the body for attachment to the flexibleshaft 20 via a natural orifice, an incision, a cannula, etc. It shouldbe appreciated that the flexible shaft 20 may be entered into the bodyvia a first orifice and that the surgical instrument or attachment maybe entered into the body via a second orifice, the first orifice beingthe same as or different than the second orifice.

With the surgical instrument or attachment so attached to the flexibleshaft 20, an end-to-end anastomosis procedure, for example, may beperformed and the flexible shaft 20 with the surgical instrument orattachment attached thereto may thereafter be withdrawn from the body.It should be appreciated that the surgical instrument or attachment maybe shaped and configured to minimize trauma during withdrawal thereof.Furthermore, it should be appreciated that the flexible shaft 20 may becaused to become limp prior to withdrawal from the body as more fullydescribed above.

FIG. 24 a shows another example embodiment of second coupling 26 of theflexible shaft 20, this example embodiment of the second coupling beingreferred to herein as second coupling 500. In accordance with thisexample embodiment, the second coupling 500 is configured to detachablycouple at a proximal side to a distal end of the flexible shaft 20, andis also configured to be disassembled, for, e.g., service, cleaning,refurbishing, repairing, diagnostic purposes, testing purposes,upgrading, etc. Moreover, it will be appreciated that in accordance withthis example embodiment, a surgical instrument or attachment may includea coupling that mates with a distal side of the second coupling 26.

Referring now to FIG. 24 a, the second coupling 500 includes a link 510which may be rigidly attached to the distal end 24 of flexible shaft 20.Link 510 includes an annular grove 515 for receiving an O-ring 520 forproducing a fluid-tight and air-tight seal between the second coupling500 and the distal cover or tip 690.

The second coupling 500 also includes an insert 535. A proximal end 530of insert 525 includes slotted cut-outs or cups 755. The cups 755 areconfigured to receive and hold distal ends of steering cables 34, 35, 36and 37 (a portion of which is shown in this figure). The insert 525 alsoincludes recesses 555 for receiving bearings 550 and a slot 526.

In this example embodiment, the steering cables 34, 35, 36, and 37include spherical distal ends 34 a, 35 a, 36 a, and 37 a, respectively,for releaseably and tensionally engaging in respective cups 755 ofinsert 525. During assembly, steering cables 34, 35, 36, and 37, whichextend from the distal end 24 of the flexible shaft 20, are passedthrough a bore 525 of the link 510. Steering the spherical distal ends34 a, 35 a, 36 a and 37 a of cables 34, 35, 36, and 37 tensionallyengage the proximal end 530 of an insert 525, urging the proximal end530 of the insert 525 into the bore 525 of the link 510, lip 535 of thelink 510 firmly engaging a proximal face 545 of a distal end 540 of theinsert 525.

Bearings 550 are received by recesses 555 of insert 525, e.g., by pressfit, friction fit, interference fit, etc. Each bearing 550 includes abore 560.

The second coupling 500 also includes a first shaft engagement member565, and a second shaft engagement member 575. A proximal end 570 of thefirst shaft engagement member 565 and a proximal end 580 of the secondshaft engagement member 575 are received in a respective one of thebores 560, e.g., by press fit, frictional fit, interference fit, etc.Each of the first shaft engagement member 565 and the second shaftengagement member 575 includes a respective annular cup member 625, 630.

In this example embodiment, annular magnets 590 are provided. Thesemagnets 590 may be used in conjunction with a Hall sensor or Hall-effectdevice, as described above. A distal end 605 of the first shaftengagement member 565 and a distal end 610 of the second shaftengagement member 575 extends through a respective bore 615 of themagnets 590. Each of the magnets 590 is non-rotatably connected to thefirst shaft engagement member 565 and the second shaft engagement member575 at first cup member 625 of the first shaft engagement member 565 andsecond cup member 630 of the second shaft engagement member 575,respectively, so as to rotate with the first shaft member 565 and thesecond shaft member 575.

A printed circuit board (“PCB”) 635 is disposed adjacent to magnets 590.PCB 635 has a first slot 640 and a second slot 645 through which thedistal end 605 of the first shaft engagement member 565 and the distalend 610 of the second shaft engagement member 575 received. PCB 635 alsoincludes contact pins 680 configured for electrically and logicallyconnection to a surgical instrument or attachment.

In accordance with this example embodiment, PCB 635 is connected to adistal end of a flexible data cable which extends through slot 526 ofinsert 525, and through bore 525 of link 510. A proximal end of theflexible data cable is configured to connected to the data transfercable 38 arranged in the flexible shaft 20. This flexible data cableallows data transfer between the data transfer cable 38 (and,accordingly, controller 122), PCB 635 and the surgical instrument orattachment.

A contact pin seal 675 is provided adjacent to PCB 635. Contact pin seal675 includes bores 685. Contact pin seal 675 receives and seals contactpins 680 of the PCB 635, such that the contact pins 680 extend partiallythrough bores 685.

Bearings 660 and 665 are also provided adjacent to a distal side 670 ofPCB 635. The distal end 605 of the first shaft engagement member 565 andthe distal end 610 of the second shaft engagement member 575 are eachreceived by a first bore 655 of the first distal ball bearing 650 and asecond bore 660 of the second distal ball bearing 665, e.g., by pressfit, frictional fit, interference fit, etc.

A distal cover or tip 690 is provided to cover the arrangement. Thedistal tip 690 includes a first bore 695, a second bore 700, and twocontact pin bores 705. Seals 710 are provided in the first bore 695 andthe second bore 700. The distal end 605 of the first shaft engagementmember 565 and the distal end 610 of the second shaft engagement member575 are each received by a first bore 695 and a second bore 700 of adistal tip 690, respectively, and extend therethrough to couple to asurgical instrument or attachment. The distal ends 605 and 610 also passthrough the seals 710. The contact pins 680 of the PCB 635 extendpartially through the contact pin bores 705 of the distal tip 690 toconnect to the surgical instrument or attachment.

The distal tip 690 is rigidly and firmly attached to the link 510 by alocking mechanism. FIG. 24 b illustrates the second coupling 500 in itsassembled state. The locking mechanism for securing the distal tip 690to the link 510 may include any suitably selected locking mechanism forfirmly securing mechanical elements, such as, for example, screws,bolts, rivets, clamps, clips, fasteners, adhesives, epoxies, sealants, aweld, a brazing, a soldered connection, an ultrasonic weld, etc. Thelocking mechanism may also be removable to allow for disassembly ofdetachable second coupling 500, so that the flexible shaft may be, forexample, cleaned, sterilized, autoclaved, maintained, repaired, partsreplaced, refurbished, etc.

Referring now to FIG. 25, there is seen a sectional view of an exampledetachable second coupling 500 fully assembled, including a flexiblestrip locking mechanism 720 for securing the distal tip 690 to the link510. The link 510 includes a first annular recess 725 and the distal tip690 includes a second annular recess 730. When the detachable secondcoupling 500 is fully assembled, the first annular recess 725 of thelink 510 and the second annular recess 730 of the distal tip 690 aresituated adjacent to one another, forming an annular cavity 735. Aannular strip 740 substantially fills the cavity 735 and preventsmovement of the distal tip 690 relative to the link 510, e.g., alonglongitudinal axis 745, thereby firmly securing the distal tip 690 to thelink 510. The annular strip 740 may be flexible and may be formed of,e.g., metal, e.g., stainless steel.

Referring now to FIGS. 26 a to 26 d, there is seen a sequence ofassembling and/or disassembling the detachable second coupling 500illustrated in FIG. 25. FIG. 26 a shows a sectional view of a detachablesecond coupling 500 fully assembled, before insertion of the flexibleannular strip 740. As is seen from FIG. 26 a, the distal tip 690includes a tangential slit 750 leading from the outer surface of thedistal tip 690 to the annular sealing cavity 735. As illustrated in FIG.26 b the flexible annular strip 740 is inserted through the tangentialslit 750 and into the annular cavity 735. An insertion pressure exertedon the annular strip 740 causes it to be flexibly guided into at least aportion of the annular cavity 735, as illustrated in FIGS. 26 c and 26d. However, it should be appreciated that the flexible annular strip 740may occupy substantially all of the annular cavity 735 after insertion.As described above, the flexible annular strip 740 prevents movement ofthe distal tip 690 relative to the link 510, thereby firmly securing thedistal tip 690 to the link 510.

To disassemble detachable second coupling 500, the flexible annularstrip 740 may be removed from the annular cavity 735, for example, bymanually pulling the flexible annular strip 740 from the annular cavity735 via the tangential slit 750. Removal of the annular slit allowsmovement of the distal tip 690 relative to the link 510, therebypermitting disassembly of the detachable second coupling 500.

Referring now to FIG. 27, there is seen a sectional view of an exampleshaft engagement member 565, 575. As shown, first shaft engagementmember 565 and second shaft engagement member 575 each include aproximal bore 760. When the second coupling is assembled and connectedto the flexible shaft 20, the first drive shaft 30 of the flexible shaft20 and the second drive shaft 32 of the flexible shaft 20 extend fromthe distal end 24 of the flexible shaft 20 through the bore 525 of thelink 510, where they releaseably and non-rotatably connect to theproximal end 570 of the first shaft engagement member 565 and theproximal end 580 of the second shaft engagement member 575,respectively, for example, by being rigidly inserted into a respectiveproximal bore 760. Each of the first drive shaft 30 and the second driveshaft 32 may include a rigid end piece adapted by size and configurationto frictionally and non-rotatably engage a respective bore 760. Itshould be appreciated that in this embodiment, the first shaftengagement member 565 and the second shaft engagement member 575 may beremovable from first drive shaft 30 and second drive shaft 32,respectively, to allow the detachable second coupling 500 to bedisassembled, so that flexible shaft 20 may be, for example, cleaned,sterilized, autoclaved, repaired, replaced, refurbished, upgraded,maintained, etc.

FIG. 29 illustrates an example PCB 635 for use within the example secondcoupling 500. As seen in FIG. 29, PCB 635 includes a memory unit 850, anoptional processing unit 855, circuitry 851 (including, for example,Hall-effect devices or Hall sensors 852), and a set of data leads 860for electrical and logical connection to the data transfer cable 38 ofthe flexible drive shaft 20. Alternatively, it should be appreciatedthat the memory unit 850 and/or circuitry 851 need not be located on PCB635 and may be located anywhere within or on the flexible shaft 20, suchas, for example, inside or on the flexible shaft 20, inside or on firstcoupling 22, and/or inside or on second coupling 500 in a differentlocation. The memory unit 850 may be in the form of, for example, anEEPROM, EPROM, etc. and may be configured, for example, to store usagedata 870 of the flexible drive shaft 20, such as, for example, thenumber of times a rotatable drive shaft 30, 32 is rotated, the number oftimes a rotatable drive shaft 30, 32 is used, the number of times arotatable drive shaft 30, 32, the number of times the flexible shaft 20has been used, the number of rotations of the rotatable drive shaft 30,32, the number of times the flexible shaft 20 has been connected and/ordisconnected from the remote power console 12 and/or a surgicalinstrument or attachment attachable to the flexible shaft 20, a date,e.g., of initial use, connection, rotation, etc. and/or any other data,etc. The memory unit 850 may also store serial number data 875 and/oridentification (ID) data 880 of the flexible shaft 20 indicating, forexample, the type of flexible shaft 20 and/or a particular flexibleshaft 20, etc. Optional processing unit 855 may be electrical andlogical connection to the memory unit 850 and may be configured to, forexample, pre-process one or more of the usage data 870, the ID data 880,and the serial number data 870 before being stored in the memory unit850. The angular position of the drive shafts 30, 32, the direction ofrotation of the drive shaft 30, 32, and/or the number of rotations ofthe drive shaft 30, 32 (e.g., using magnets 590), etc., may bedetermined and/or determinable in accordance with signals from the Hallsensors 852.

It should be appreciated that a particular flexible shaft 20 may bedesigned and configured to be used a single time, multiple times, apredetermined number of times, etc. Accordingly, the usage data 870 maybe used to determine whether the flexible shaft 20 has been used and/orwhether the number of uses has exceeded a maximum number of permitteduses. As more fully described above, an attempt to use a flexible shaft20 after the maximum number of permitted uses has been reached may causean ERROR condition.

Referring now to FIGS. 28 a, 28 b and 28 c, there is seen an exampleconnection mechanism 800 configured to connect a surgical instrument orattachment (e.g., surgical stapler attachment 250) to the secondcoupling 500 of the flexible shaft 20. Other connection mechanisms are,of course, possible. In this example embodiment, assume, for example,that each of the distal ends 605, 610 of shaft engagement members 565,575 is represented by engagement shaft 835. Assume also, for example,that a proximal end of a surgical instrument or attachment includes acoupling (e.g, coupling 260) having a first connector (e.g., for drivingdrive shaft 262) and a second connector (e.g., for driving drive shaft266) configured as an engagement member 805.

The engagement shaft 835 includes a number of grooves 840. Theengagement member 805 has a bore 810 and two longitudinal slits 820. Aclip 825 having flanges 830 is inserted in the bore 810 of theengagement member 805. It should be appreciated that engagement member805 may include any number of longitudinal slits 820 and that there maybe a corresponding number of flanges 830 of clip 825 received by thelongitudinal slits 820.

Engagement shaft 835 is inserted in the bore 810 of the engagementmember 805, with at least one of the flanges of the 830 engaged, e.g.,frictionally, with a grooves 840 of the engagement shaft 835. In thismanner, the engagement shaft 835 and the engagement member 805 may bereleasably and non-rotatably coupled.

Although in this example embodiment, FIGS. 28 a, 28 b, and 28 cillustrate a respective engagement member 805 as part of each of thecoupling of the surgical instrument or attachment, and the engagementshaft 835 as part of first and second shaft engagement members 565, 575,it should be appreciated that in another example embodiment, the firstand second shaft engagement member 565, 575 may include an engagementmember 805 and the coupling of the surgical instrument or attachment mayinclude engagement shafts 835.

Referring now to FIG. 31, there is seen an example flexible shaft 20including a moisture sensor 990 configured to detect moisture within theflexible shaft 20. FIG. 31 shows moisture sensor 990 disposed within thesecond coupling 500 (e.g., mounted on PCB 635). Moisture sensor 990 iscoupled to the data transfer cable 38 to communicate an indication ofthe presence of moisture (e.g., sensed moisture data is communicated) tothe remote power console 12. The presence of moisture within theflexible shaft 20 may cause corrosion of the components of the flexibleshaft 20, such as, for example, the rotatable drive shafts 30, 32,electronic or electrical components arranged in the flexible shaft 20,etc. In accordance with and/or based on the sensed moisture data, theremote power console 12 may communicate the presence of moisture to auser, such as, for example, by audible or visual signal.

Referring now to FIG. 32, there is seen an example moisture sensor 990including a first printed lead 995 and a second printed lead 996, eachof which is printed on board element 997 and connected to the datatransfer cable 38. The presence of moisture may change the electricalconductivity between the printed leads 995, 996, e.g., the electricalresistance between the printed leads 995, 996 may vary in accordancewith the amount of moisture present.

It will be appreciated that a moisture sensor 900 may additionally oralternatively be disposed within the elongated sheath of the flexibleshaft 20, and coupled to, e.g., data transfer cable 38.

In some cases, the user of the surgical device 10 may desire to make aportion of the flexible shaft 20 rigid (relative to the flexibility offlexible shaft 20). Accordingly, referring now to FIGS. 30 a, 30 b, and30 c, there is seen an example shape-retaining sleeve 900 for makingrigid or maintaining a desired shape of at least a portion of theflexible shaft 20. FIG. 30 a illustrates an exploded view of theshape-retaining sleeve 900, FIG. 30 b illustrates an assembled view ofthe shape-retaining sleeve 900, and FIG. 30 c illustrates a sectionalview of the shape-retaining sleeve 900. The shape-retaining sleeve 900includes an elongated sleeve or shaft member 905 having a bore 960extending therethrough, and a positioner or securing device 901including housing member 910 having a bore 925 extending therethrough, asecuring knob 915 having a bore 965 extending therethrough, and anO-ring 920. It should be appreciated that the sleeve member 905 may beconstructed from a rigid non-bendable material or, alternatively, may beconstructed from a material capable of being deformed into differentconfigurations or shapes, but generally retaining its shape oncedeformed.

In the example embodiment illustrated in FIGS. 30 a to 30 c, the sleevemember 905 is rigidly received within at least a portion of the bore 925of the housing member 910. As illustrated in FIG. 30 c, bore 925 mayhave a proximal portion 940 having a larger diameter than a distalportion 945. A distal end 955 of the securing knob 915 is rigidlyreceived within the proximal portion 940 of the bore 925. Helicalthreads may be provided on the inside surface of the proximal portion940 of the bore 925 and the outer surface of the distal end 955 of thesecuring knob 915 to permit the securing knob to be screwed into place.Alternatively, for example, the securing knob 915 may frictionally andslidably engage within the proximal portion 940 of the bore 925. TheO-ring 920 is received within the proximal portion 940 of the bore 925and urged against an interface 950 between the proximal and distalportions 940, 945 of the bore 925 by the distal end 955 of the securingknob 915. Compression of the O-ring at the interface 950 urges at leasta portion of an inner annular surface 975 of the O-ring 920 inwardly ina radial direction indicated by arrows 980, thereby frictionallyengaging and securing a flexible shaft 20 inserted in the sleeve member905 through the O-ring 920. When fully assembled, the bores 960, 925,965 are disposed adjacent to one another, forming a continuous channel970 for receiving at least a portion of the flexible shaft 20.

At least a portion of the flexible shaft 20 may be inserted through thecontinuous channel 970 for maintaining rigid at least the portion of theflexible shaft 20 in a predefined or predefinable shape, in accordancewith the predefined or predefinable shape of the sleeve member 905. Thedistal end 24 of flexible shaft 20 extends through the continuouschannel 970 and beyond at least a portion of a distal end 985 of thesleeve 900, the second coupling 26 detachably securable to the distalend 24 of flexible shaft 20. As described above, the receipt of thesecuring knob 915 by bore 925 causes the inner annular surface 975 ofO-ring 920 to frictionally and securely engage the flexible shaft 20,thereby holding it firmly in place. It will be appreciated that thesleeve 900 may be retained or secured in a selected longitudinalposition along the flexible shaft 20 via the securing device 901. Thesleeve 900 generally retains the flexible shaft 20 in a predetermined orpredeterminable shape.

It should be appreciated that the securing knob 915 may frictionallysecure the flexible shaft 20 by other arrangements other than the O-ring920, such as, for example, by threaded engagement, compressiveengagement, clamping, gluing, pasting, etc. It should also beappreciated that use of the shape-retaining sleeve is optional, i.e.,the flexible shaft may be usable without the shape-retaining sleevebeing employed.

The several aforementioned objects and advantages of the presentinvention are most effectively attained. Those skilled in the art willappreciate that numerous modifications of the exemplary embodimentdescribed hereinabove may be made without departing from the spirit andscope of the invention. Although a single exemplary embodiment of thepresent invention has been described and disclosed in detail herein, itshould be understood that this invention is in no sense limited therebyand that its scope is to be determined by that of the appended claims.

1-33. (canceled)
 37. A sleeve, comprising: an elongated shaft configuredto receive a flexible shaft therein; and a securing arrangementconfigured to selectively and variably retain the elongated shaft inanyone of a number of longitudinal positions along the flexible shaft.38. The sleeve according to claim 37, wherein the elongated shaft is agenerally shape-retaining shaft, the shaft configured to retain alongitudinal portion of the flexible shaft in a predetermined shape. 39.The sleeve according to claim 37, wherein the arrangement includes ahousing including an o-ring, the arranged configured to retain theelongated shaft in a selected one of the longitudinal positions bycompressing the o-ring.
 40. A shaft arrangement, comprising: anelongated flexible sheath; at least one flexible drive shaft disposed inthe flexible sheath; a shape-retaining sleeve, at least a portion of theflexible sheath being disposed in the shape-retaining sleeve, theshape-retaining sleeve configured to maintain the at least portion ofthe flexible sheath in a predetermined shape; and an arrangementvariably securing the shape-retaining sleeve to the flexible sheath inanyone of a number of longitudinal positions along the flexible sheath.41. A surgical system, comprising: an electro-mechanical driver; anelongated, flexible sheath; at least one drive shaft disposed within theflexible sheath; a surgical attachment coupled to the at least one driveshaft, the electromechanical driver configured to drive the surgicalattachment; a shape-retaining sleeve, at least a portion of the flexiblesleeve being disposed in the shape-retaining sleeve, the shape-retainingsleeve configured to maintain the at least portion of the flexiblesheath in a predetermined shape; and an arrangement variably securingthe shape-retaining member to the flexible sheath in anyone of a numberof longitudinal positions along the flexible sheath.
 42. A sleeve,comprising: a shape-retaining sleeve configured to receive a flexibleshaft therein, the elongated shaft, the shape-retaining sleeveconfigured to maintain at least a portion of the flexible shaft in adesired shape.
 43. The sleeve according to claim 42, further comprising:an securing arrangement configured to selectively and variably retainthe elongated shaft in anyone of a number of longitudinal positionsalong the flexible shaft.
 44. A flexible shaft, comprising: a flexible,elongated outer sheath formed from an autoclavable material; and a driveshaft disposed within the outer sheath.
 45. The flexible shaft accordingto claim 44, wherein the outer sheath is formed from a combination of afluoropolymer and silicone.